ABSTRACT

This Culture Change and Data Measurement tool is all about INPUTS. In my experience, most underperforming companies put a lot of effort into OUTPUTS such as rework and third-party inspection = COST and variable quality results. Are CRITICAL TO QUALITY Characteristics all about OUTPUT? NO THEY ARE NOT! For me, it is as CRITICAL TO QUALITY to validate the INPUT parameters and processing windows that give you the product being produced. Typical parameters being TIME, TEMPERATURE, PRESSURE, and MIX RATIOS. The objective here is to highlight the vital importance it is to VALIDATE INPUT parameters and the need to take ACTION if ACTUALS are outside of the processing window that will affect quality. In essence, why would you press the trigger or button without knowing the INPUTS were within standard +/− tolerance to be able to give A RIGHT FIRST TIME Quality Product (OUTPUT)? Why press the button or the trigger if a critical to quality characteristic is out of specification and will generate a defect or a defective product?